Gut Microbiota And Radiotherapy

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02559349

Enrollment

Registered

2015-09-24

Start date

2015-09-30

Completion date

2019-12-31

Last updated

2020-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Tumor

Keywords

Stereotactic Body Radiotherapy, SBRT

Brief summary

A pilot, single arm, single center study to determine the feasibility of obtaining stool samples from adult patients receiving SBRT to a lung tumor, if SBRT induces changes in the gut microbiota and to obtain preliminary data about possible correlation of baseline composition and changes in gut microbiota with tumor response, local control, and development of pneumonitis/other side effects.

Interventions

OTHERStool Collection

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patient is planned to receive Stereotactic Body Radiotherapy (SBRT) to a lung lesion (either presumed or biopsy-proven NSCLC * Age 18 years old or older * Patient capable of giving informed consent

Exclusion criteria

* Use of antibiotics, antifungal, antivirals or antiparasitics during the 4 weeks prior to registration * Active infection with oral temperature \>100°F * Use of corticosteroids, methotrexate or immunosuppressive drugs during the 4 weeks prior to registration * Use of chemotherapy during the 4 weeks prior to radiotherapy or during radiotherapy. Chemotherapy cannot begin before the collection of the 30-day post treatment sample (S4). * Confirmed or suspected HIV, HBV or HCV * Chronic constipation (bowel movements less frequent than every other day) * Active uncontrolled gastrointestinal disorders such as inflammatory bowel disease, moderate/severe irritable bowel syndrome, persistent, infectious gastroenteritis, colitis or gastritis, persistent or chronic diarrhea of unknown etiology, Clostridium Difficile infection (recurrent) or Helicobacter Pylori infection (untreated) * Major surgery of the GI tract, with the exception of cholecystectomy and appendectomy, in the past five years. Any major bowel resection at any time * Patients on anti-diarrheal medications * Patients on probiotics

Design outcomes

Primary

Measure	Time frame
Number of subject providing stool samples	2 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026